System for use in a dialysis apparatus

ABSTRACT

An apparatus and a method for filling a container containing a dry powdered salt concentrate for use in dialysis with purified fluid and removing the trapped air or gases generated during the filling of the container, while maintaining the required fluid level in the container and without the need for evacuating gases from the container prior to filling.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 12/626,348 filed Nov. 25, 2009, now U.S. Pat. No. 8,409,445.

BACKGROUND OF THE INVENTION

Dialysis is performed as a treatment for patients suffering from renalinsufficiency. Dialysis can be performed either in the peritoneum, orthrough extracorporeal dialysis or filtration of blood. These twodialysis methods have in common the fact that dialysis fluids ordialysates take up the degradation products of metabolism. Thesedialysates usually contain high levels of sodium chloride and otherelectrolytes, such as calcium chloride, or potassium chloride, a buffersubstance, such as bicarbonate, or acetate and acid to establish aphysiological pH, plus optionally, glucose or another osmotic agent.

Dialysates are either supplied as ready-to-use solutions or they areprepared on site from concentrates, including solid concentrates. Solidsoffer the advantage of a small package volume and a low weight. Althoughsolids also have disadvantages—electrolyte salts, for example, arehighly hygroscopic—there is a trend toward offering only solidcomponents for preparation of dialysates.

In the above mentioned hemodialysis systems, a flexible bag or containerfilled with a powdered salt concentrate is used to generate aconcentrated salt solution. Purified fluid is added to the top of thecontainer and the concentrated solution is removed from the bottom ofthe container. When the concentrated solution is removed from the bottomof the bag it is generally delivered to the hemodialysis machine for usein the dialysate. It is important that the fluid level in the containerwith the salt concentrate is maintained above the level of the salt inthe container, when the solution is being pumped out of the bottom ofthe container. Under normal operation, the fluid level above thepowdered salt layer is maintained or increases as the salt concentrateis consumed. However, if the fluid level falls below the level of thesalt concentrate, air or gases in the bag may be pumped through the saltconcentrate and out of the bottom of the container into the dialysate.

During hemodialysis, using systems such as described in U.S. Pat. No.5,385,564 and U.S. Pat. No. 5,616,305, incorporated by reference herein,dry bicarbonate or acid concentrate is mixed with dialysate via acontainer using one or more ports. Even when the container is filledthere is always air remaining in the container. The system cannot removeall of the air from the container without evacuating the air from thecontainer via a vacuum system to create negative pressure, beforefilling the container with fluid.

To deter air from being drawn into the hydraulics of the machine duringoperation, it is desirable to fill the container with a sufficientvolume or fluid to maintain a fluid layer above the dry powder. In thesystems known in the art, without removing air from the bag via avacuum, some containers will not maintain the correct fluid layer, andthus, extra air passes into the hydraulics which requires excessiveventing procedures. The new method and arrangement of the presentinvention solves the problem without the need to generate a vacuum toevacuate the gases from the concentrate.

BRIEF SUMMARY OF THE INVENTION

In an embodiment, the present invention provides a system and a methodfor filling a container containing a dry powdered salt concentrate withpurified fluid for use with a dialysis apparatus. According to adisclosed method, the trapped air or gases generated during the fillingof the container are forced out of the container without the creating avacuum in the container prior to filling.

According to a disclosed method, fluid is rapidly pumped into acontainer having a dry powdered salt concentrate. When the interior ofthe container reaches a first pressure, contents of the container,including residual and generated gases as well as some fluid, arepermitted to flush from the container, and out eventually out of thesystem. During this flushing step, adequate fluid is provided tomaintain the first pressure within the container. At the conclusion ofthe flushing step, the pressure in the container is reduced to a second,lower operating pressure, and the system begins regular operation withdelivery of solution to the dialyzer. According to various embodiments,the flushing step may proceed for a set time, or until such time a givenlevel of air is no longer detected in the solution leaving the containerfor a given period of time.

In another embodiment, the present invention also provides a system forremoving gases from a container having a powdered salt concentrate foruse in a dialysis apparatus. The system further includes a fluid source,a pump which is in fluid communication with the fluid source, at leastone hydraulic line having one end in fluid communication with the fluidsupply and a second end in fluid communication with a drain. The systemfurther includes a bypass valve that is disposed downstream from thefirst pump and upstream from the inlet of the container. The valve iscapable of directing fluid flow into the hydraulic line or into thecontainer. An outlet of the container is in fluid communication with thehydraulic line downstream from the bypass valve. A pressure sensormonitors the pressure of the fluid pressure in the container.

In an embodiment, a second valve is provided downstream the container tofacilitate pressurization of the container. In another embodiment an airsensor is provided to detect gases in the solution flowing from thecontainer.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a schematic diagram the general environment where the systemis operating. A patient is shown attached to a dialysis apparatus. It isunderstood that the system of the present invention supplies dialysatesolution to such an apparatus for use in hemodialysis.

FIG. 2 is a schematic diagram of an embodiment of a system for theproduction and discharge of a liquid hemodialysis concentrate for use ina dialysis apparatus.

FIG. 3 is a representative drawing of an embodiment of a containerhaving a powdered salt concentrate that can be used in the method andsystem of the present invention.

FIG. 4 is a partially cross-sectioned view of an embodiment of acontainer having a powdered salt concentrate that can be use in themethod and system of the present invention.

FIG. 5 is a schematic diagram of an embodiment of a system for theproduction and discharge of a liquid hemodialysis concentrate for use ina dialysis apparatus.

DETAILED DESCRIPTION OF THE INVENTION

For the purposes of this disclosure, the term “operating pressure” meansthe fluid or fluid pressure in the container having a powdered saltconcentrate, during operation of the system, where the system is capableof supplying a concentrated salt solution to the dialysis apparatus. Theterm “flushing step” means operating the system to remove trapped gasesfrom a container having a powdered salt concentrate, by pumping fluidthrough the container at a pressure that is greater than the operatingpressure of the system, and directing the outflow out of the system to adrain, instead of to a dialysis apparatus.

Turning now to the drawings, FIG. 1 displays the general context of adialysis system 10. The dialysis system 10 includes the dialyzer 11, anda subsystem 12 for preparing a salt solution from a powdered saltconcentrate for use in the dialyzer 11. The salt solution is provided tothe dialyzer 11 for administration to a patient 13. The dialysis system10 may additionally include various other optional subsystems andequipment.

FIG. 2 illustrates a representative hydraulic arrangement of thedialysis system 10. By way of a general overview of the operation, thesystem 10 includes a main hydraulic line 20 a-d that is fluidly coupledto a fluid source 22 at one end, and to the dialyzer 11 at the otherend, with various optional assemblies disposed along the mainline 20. Itis noted that the mainline 20 a-d may include a plurality of hydrauliclines. In the illustrated embodiment, optional assemblies are disposedalong the mainline 20 in addition to the subsystem 12 for preparing asalt solution and may include a hydroblock 24 and one or more balancingchambers 26, 28. A return line 30 a-f from the dialyzer 11 providesreturn flow from the dialyzer 11 to a drain 34. As with the mainline,the return line 30 a-f may include a plurality of hydraulic lines.Subassemblies such as an air separation chamber 36 or a heat exchanger38 may be provided along the return line 30. It is noted that not allelements of the illustrated hydraulic arrangement are necessary to thestructure and operation of the subsystem 12 for preparing a saltsolution from a powdered salt concentrate, although a generalexplanation is provided herein in the interest of completeness.

Turning now to the specifics of the illustrated hydraulic arrangement,the fluid source 22 may include any appropriate type of fluid or fluids.For example, a reverse osmosis fluid (RO fluid) source may be provided.It will be appreciated that an alternate fluid may be provided asrequired by the system 10. While the fluid referenced in this disclosurewill be fluid, it is intended that the terms “fluid” and “fluid” willencompass other appropriate fluids for the purposes of the disclosedmethod and arrangement.

Fluid from the fluid source 22 flows through mainline 20 a to thehydroblock 24. In this embodiment, the heat exchanger 38, a pressureregulator 40, and a control valve 42 are provided along the mainline 20a between the fluid source 22 and the hydroblock 24. While the valve 42controls overall flow to the mainline 20 a, the pressure regulator 40may control the pressure of the fluid as it passes through this sectionof the mainline 20 a. The heat exchanger 38 may heat the fluid somewhatwith heat from the return spent fluid, as will be discussed below.

The illustrated hydroblock 24 is a multichambered unit, the fluid beingheated by a heater 41 in chamber 24 b and vented to a vent 42 in chamber24 c as the fluid flows through the various chambers 24 a-e of thehydroblock 24. The fluid temperature within the hydroblock 24 may bemonitored and/or controlled by a control thermostat 44. A deaerationpump 46 pumps fluid between the forth and fifth chambers 24 d, 24 e ofthe hydroblock 24 to return the fluid to the mainline 20 b.

Leaving the hydroblock 24, the mainline 20 b bifurcates at a branchpoint 50. Valves 52, 54 control the flow of fluid to the continuingmainline 20 c and a subsystem line 56, respectively. If the valve 54 isclosed and valve 52 open, the fluid continues through the valve 52 tothe mainline 20 c. If the valve 54 is open and the valve 52 closed,fluid proceeds through valve 54 to the subsystem line 56. As with all ofthe valves in this disclosure, the valves 52, 54 may be simple shut-offvalves, or other multiposition valves. For example, valves 52, 54 may bereplaced by a single valve that includes positions that arrest flowentirely, that direct flow to the subsystem line 56, or that direct flowalong the mainline 20 c.

Returning to FIG. 2, the subsystem line 56 connects flow from themainline 20 b to the subsystem 12 for preparing a salt solution, as willbe explained in greater detail below. After leaving the subsystem 12,the salt solution is returned to the mainline 20 c at least one ofjunction 58 or 60. The continuing mainline 20 c directs flow to thebalance chambers 26, 28, flow through the balancing chambers 26, 28being controlled by a plurality of valves 62-69. Each of the balancingchambers 26, 28 includes two separate subchambers separated by aflexible membrane, the significance of which will be discussed below.Flow from the subsystem 12 flows into the respective balancing chambers26, 28 through valves 62 and 64, and out from the balancing chambers 26,28 through valves 66, 68.

Leaving the balancing chambers 26, 28, the fluid from the subsystem 12is directed through mainline 20 d. Flows to and from the dialyzer 11 arecontrolled by a pair of control valves 70, 72 disposed along themainline 20 d and the return line 30 a, respectively. Thus, fluid fromthe balancing chambers 26, 28 flowing through mainline 20 d moves on tothe dialyzer 11 when dialyzer inlet valve 70 is in the openconfiguration, and bypass valve 74 in the bypass line 30 b is in theclosed position.

Following usage in the dialyzer 11, spent fluid passes the control valve72 to return to the system 10 through return line 30 a and 30 c with thebypass valve 74 is in the closed position. To ensure accurate operationof the balancing chambers 26, 28, as discussed below, spent fluid passesinto the air separation chamber 36. From the air separation chamber 36,separated gases, and potentially fluid, are passed through return line30 d to the drain 34 by opening shutoff valves 76 and 80. Return fluid,from which the gases have been separated in the air separation chamber36, may be pumped by flow pump 78 through return line 30 e to one orboth of the balance chambers 26, 28 through valves 63, 65. Leaving thebalance chambers 26, 28 through valves 67, 69, respectively, the spentfluid is directed to a heat exchanger 38 and the drain 34 by way ofreturn line 30 f, overall flow to the drain 34 being controlled byshutoff valve 80. It will be appreciated that the heated spent fluidpassing through the heat exchanger 38 may be used to heat the fluidflowing from the fluid source 22 to the hydroblock 24.

Operation of the balance chambers 26, 28 is known in the art. Within thebalance chambers 26, 28, fresh fluid from the subsystem 12 passes alongone side of the internal membranes, while spent fluid passes along theother side of the internal membranes. As will be appreciated by those ofskill in the art, this pumping of spent fluid from line 30 e along oneside of the membrane with fresh fluid passing along the other side ofthe membrane results in a balanced provision of fluid from and to thedialyzer 11 during use.

Returning now to the structure and operation of the subsystem 12 forpreparation of a salt solution, as explained in detail above, fluidflowing from the mainline 20 b from the hydroblock 24 may be directed tothe subsystem 12 by opening the control valve 54 and closing controlvalve 52 at adjacent junction 50 to provide flow to the subsystem line56. To prepare the salt solution, fluid from the subsystem line 56enters a container 82, which contains a powdered salt concentrate. Thecontainer 82 may be of any appropriate design, and may include aso-called bi-bag, which is a collapsible, replaceable bag that enclosesthe powdered salt concentrate. As utilized in this disclosure, the term“container” 82 will be used to designate any or all of a rigidcontainer, semiflexible container, or a bi-bag.

An example of a container 82 in accordance with the disclosed method isshown in FIG. 3. In this view, a protective cover has been removed toreveal the components of the container 82. The container 82 may becoupled to the subsystem 12 by any appropriate arrangement. In theillustrated embodiment, the container 82 is coupled to the subsystem 12by a connector 88 having an inlet 90 and an outlet 92. As illustrated,the container 82 contains a dry powdered salt concentrate for use inpreparation of a salt solution of a dialysate mixture.

FIG. 4 shows a partially cross-sectioned view of a container 82 having aprotective cover 94 in place. A connector 88 may be utilized to couplethe container 82 to the system 10. In order to allow the entry of fluidinto acid the removal of the salt solution from the container 82, aninlet 90 and an outlet 92 are provided. Although the inlet 90 and outlet92 are shown in an upper portion of the container 82, the inlet 90 andoutlet 92 may be alternately disposed, so long at the requisite mixingis obtained as provided by the disclosed method. For example, the inletmay be disposed in a lower portion of the container 82 to allow thefluid to be injected upward into the container 82 to encourage agitationto facilitate mixing.

In order to allow the mixed salt solution to be withdrawn from acontainer 82 that is not completely full, the outlet 92 originates belowthe level of fluid in the container 82. In the illustrated embodiment, atube 96 having a lower opening 98 is fluidly coupled to the outlet 92such that the opening 98 may be disposed in a lower portion of thecontainer 82, that is, below the fluid level. To inhibit the intake ofpowdered salt that is not yet dissolved, a filter 100 may be disposed atthe opening 98. The filter 100 may be made of any appropriate material,such as, for example, porous polyethylene.

The container 82 and the connector 88 may likewise be made of anyappropriate material, and may be the same as or different from oneanother. By way of example only, either or both may be made of highdensity polyethylene or similar materials. The flexible container 82 maylikewise be made of any suitable material, such as, by way of exampleonly, a polyamide-polyethylene coextruded film.

The container 82 contains a dry form of one or more of any suitablesalts used for preparation of dialysis solution. By way of example only,such suitable salts include sodium bicarbonate and sodium acetate. Itwill be understood by those of ordinary skill in the art that, when thepowdered salt is sodium bicarbonate in particular, carbon dioxide willtypically be generated from the initial contact between the fluid andthe bicarbonate powder. Residual air is likewise often disposed withinthe container 82. As explained above, in order to provide proper removalof the salt solution from the container 82, it is necessary to maintainthe opening 98 into the outlet 92 of the container 82 below the surfaceof the fluid contained therein. It will thus be appreciated that areduction of gases disposed within the container 82 typically providesmore space for the introduction of fluid.

In order to expel air from the subsystem 12, an air separation chamber102 may be provided downstream the container 82. The air separationchamber 102, which is fluidly connected to the container 82 by thesubsystem line 56, is designed to remove both air residually disposedwithin the container 82 and gases precipitating out of the bicarbonatesolution when fluid is introduced to the powdered salt during operationof the subsystem 12.

In the illustrated embodiment, an air sensor 114 is provided on the airseparation chamber 102. It will be appreciated that the air sensor 114may be alternately disposed and may be of any appropriate design. Forexample, the air sensor 114 may be a two-pronged air detection probelocated at the top of the air separation chamber 102 such that anelectric current between the two prongs is detected when fluid fills thechamber 102 to at least the level of the prongs. Conversely, when thereis air in the chamber 102, the air between the two prongs acts as aninsulator and electric current does not flow.

Flow through the air separation chamber 102 is controlled by a controlvalve 104. If air is not detected in the air separation chamber 102, thecontrol valve 104 is closed, the solution proceeds through subsystemline 108, advanced by a pump 110 to rejoin the mainline 20 c at junction58. The solution is then passed on to the balance chambers 26, 28 and tothe mainline 20 d for delivery to the dialyzer 11.

Conversely, if the air sensor 114 detects air in the air separationchamber 102, the control valve 104 is opened, and air is vented from theair separation chamber 102 through a degassing line 106 before rejoiningthe mainline 20 c at junction 60. Upon rejoining the mainline 20 c, thegas is passed to the balance chambers 26, 28 and to mainline 20 d; withdialyzer valves 70 and 72 closed, the gas travels through return lines30 b and 30 c, through air separation chamber 36, as explained above,before being expelled to the drain 34 through line 30 d.

While it is known to withdraw air from the container 82 by way of avacuum prior to introduction of fluid to the powdered salt, thedisclosed method does not utilize such a vacuum to remove all of the gasfrom the container 82 before the introduction of fluid, as in the priorart. Rather, the disclosed method provides the desired layer of fluidover the powdered salt in the container by minimizing air in thecontainer 82 after the introduction of fluid thereto. The disclosedmethod will be explained first with reference to the basic structure forperforming the claimed method (see FIG. 5), and second with regard tothe more detailed commercial embodiment of the system discussed above(see FIG. 2). Following these explanations, the operations of therespective systems by way of a controller are discussed.

Turning first to FIG. 5, there is illustrated a system 10 a forproviding dialysate to a dialyzer 11 a. For ease of understanding, thesame reference numerals followed by the letter “a” are generallyutilized to designate similar structures, with the exception of mainline20, for which no modifier is utilized.

A mainline 20 fluidly couples a fluid source 22 a, a subsystem 12 a forthe preparation of a salt solution, a drain 34 a, and the dialyzer 11 a.The subsystem 12 a includes a container 82 a which includes a powderedsalt. A pump 46 a pumps fluid passing through a heater and deaerator 24from the fluid source 22 a to container 82 a or to mainline 20 c,depending upon which of valves 54 a, 52 a is open. When valve 54 a isopen and valve 52 a is closed, fluid is directed to the container 82 a.Conversely, when valve 52 a is open and valve 54 a is closed, fluid fromthe pump 46 a bypasses the subsystem 12 a entirely.

According to the disclosed method, with valve 54 a open, valve 104 aclosed, and pump 110 a disabled, the pump 46 a pumps fluid into thecontainer 82 a until the pressure within the container 82 a reaches aspecified, first pressure level. In the arrangement of FIG. 5, valve 54a periodically closes to allow a pressure sensor 112 a to read thepressure within the line and container 82 a. When the detected pressurereaches the specified, first pressure level, a flushing step isinitiated by opening the downstream valve 104 a. In the flushing step,the salt solution is then pushed from the container 82 a while adequateadditional fluid is introduced to the container 82 a to maintain thespecified pressure. This rapid flushing results in the expulsion of boththe aqueous salt solution and gas.

During the flushing step, the valves 70 a, 72 a to and from the dialyzer11 a are closed to isolate the dialyzer 11 a from the remainder of thesystem 10 a. With valve 104 a open and valve 52 a closed, the fluid andexpelled gas are directed through open bypass valve 74 a to the drain 34a. During this flushing step, the pump 46 c continues to provide fluidto the container 82 a to maintain the pressure in the container 82 a atthe first pressure level.

The flushing step continues for either a preset period of time or untilsuch time as gas is no longer detected in the expelled fluid, as by anair sensor 114 a, for example, for a given period of time. The requiredflush time depends upon the volume of powdered salt disposed within thecontainer 82 a, greater amounts of solution requiring a more lengthyflush time period.

As discussed above, while the valves of the illustrated embodiment aresimple two position shut off valves, alternate arrangements areenvisioned. By way of example only valves 70 a and 74 a could bereplaced with a three position valve that shuts off flow entirely,directs flow to the dialyzer, or directs flow to the drain 34 a.

When the flushing step is completed, the valve 74 a is closed to directflow to the dialyzer inlet valve 70 a as the container 82 a beginsnormal operation at a second, lower operating pressure. During normaloperation, the container 82 a is filled with fluid as necessary tomaintain the lower operating pressure, as the resultant fluid isdirected to the dialyzer 11 a.

The disclosed process of rapidly and immediately pushing fluid throughthe bag reduces the amount of gas that vents into the top of thecontainer 82 a, and, instead, pushes the gas out of the bottom of thecontainer 82 a in the flushing step. The expelled gas includes bothresidual gases in the container and the powdered salt, as well as carbondioxide generated when fluid first makes contact with the powdered salt.It will be appreciated that the resultant reduction in gas within thebag provides additional room for the layer of fluid over the powderedsalt.

The differences between the first pressure, that is, the flush pressure,and the second pressure, that is, the normal operation pressure, may beas appropriate to obtain the desired results. In an embodiment, thepressure in the container 82 a during the flushing step can be raisedanywhere from two to five fold over the operating pressure of thesystem, depending on the type of container and system. In an embodiment,the container 82 a is pressurized in range between about 0.5 to 5 timesthe operating pressure, preferably between about 1 to 4 times theoperating pressure, more preferably between about 1.5 to 3 times theoperating pressure. In another embodiment, the pressure in the container82 a is maintained at about 2 times the operating pressure during theflushing step.

By way of example only, the fluid and trapped gases may be flushed fromthe system for a period of time ranging from 5 seconds to 5 minutes,depending upon aspects of the arrangement, including, for example, thevolume of the container 82 a and the amount of powdered salt containedtherein. In various embodiments, the flushing step can last anywherefrom 10 seconds to 2 minutes, 30 seconds to 2 minutes, 20 to 60 seconds,or about 30 seconds.

It will be appreciated that the system 10 a may include additional fluidlines and components, such as, by way of example only, one or more ofthe components illustrated in FIG. 2 and explained in more detail above.Referring to FIG. 2, with valve 54 open and valve 52 closed at junction50, the pump 46 moves fluid from the fluid source 22 through mainline 20b and subsystem line 56 to the container 82. With valve 104 closed andpump 110 disabled, pressure rises within the container 82 as fluidcontinues to be pumped into the container 82 by pump 46. When thepressure within the container 82 reaches a preset first pressure level,as measured by the pressure sensor 112, valve 104 is opened to initiateflushing of salt solution and gases from the container 82. The saltsolution and entrained gases are then pushed from the container 82 inthe flushing step, while the pump 46 provides additional fluid adequateto maintain the specified pressure within the container 82.

In the embodiment of FIG. 2, the flushed solution and gas enter the airseparation chamber 102. Upon opening valve 104, the gas and flushedsolution from the air separation chamber 102 flow through valve 104 anddegassing line 106 to junction 60, where it rejoins the mainline 20 c.The gas and flushed solution then proceed through one or both of valves62, 64 into one or both of the balance chambers 26, 28, and out of oneor both of valves 66, 68 to mainline 20 d.

With the dialyzer 11 isolated from the system 10 by closed input andoutlet valves 70, 72, and with bypass line 30 b and valve 74 open, theexpelled fluids and gas pass through return line 30 c to air separationchamber 36. In air separation chamber 36, while a portion of the fluidmay be separated from the gases, the gases and potentially fluid aredirected through open valve 76 to return line 30 d and open valve 80 tothe drain 34. During this flushing step, or during the subsequentrecovery step, pump 78 may pump the separated fluid within the airseparation chamber 36 through return line 30 e to one or both of thebalance chambers 26, 28 through valves 63, 65. From the balance chambers26, 28, the fluid moves through open valves 67, 69 to an optional heatexchanger 38, on through open valve 80 to the drain 34.

In an embodiment, the pressure in the container 82 can range betweenabout 10 mmHg and 500 mmHg, preferably between about 50 mmHg and 300mmHg, and more preferably between about 100 mmHg and 200 mmHg. By way ofexample only, the container 82 may be maintained at 150 mmHg, while theoperating pressure of the arrangement is on the order of 90 mmHg.

In order to detect when air is no longer present in the fluid enteringthe air separation chamber 36, the air separation chamber 36 may includean air sensor 116 similar to the air sensor 114 of the air separationchamber 102. Although the air sensors 114, 116 are provided on the airseparation chamber 102 and air separation chamber 36, they may bealternately disposed or additional sensors may be provided. At theconclusion of a set time period, or when gas is no longer detected byeither one or both of the air sensors 114, 116, the flushing step may bediscontinued, and the pressure within the container 82 reduced to aregular system operating pressure, as measured by the pressure sensor112 or other appropriate sensor.

During this recovery step, pump 78 may be engaged to pump any fluidsaccumulated in the air separation chamber 36 to the drain. Whenswitching over to regular operation, pump 110 may be engaged to pumpsalt solution to join mainline 20 c at junction 58, and the valve 104may be closed until such time as air is again detected by the air sensor114. At this time, the bypass valve 74 is closed to direct flow to thedialyzer 11, and the valves 70, 72 may be reopened as appropriate todirect flow to and from the dialyzer 11. During regular operation of thesystem, the pump 46 is operated to maintain a desired system operatingpressure; this second pressure in the container 82 is lower than thefirst pressure utilized in the flushing step of the process.

During regular operation, the air separation chamber 102 separates gasfrom fluid in the salt solution progressing to the dialyzer 11, whilethe air separation chamber 36 separates gas from spent fluid returningfrom the dialyzer 11. It will be appreciated that this elimination ofthe gases in the fluids flowing to and from the dialyzer 11 facilitatesefficient and accurate operation of the balancing chambers 26, 28 duringregular operation of the system 10.

As with the process explained with regard to FIG. 5, the disclosedprocess of rapidly and immediately pushing fluid through the container82 in the system 10 of FIG. 2 reduces the amount of gas that vents intothe top of the container 82, and, instead, pushes the gas out of theoutlet 92 of the container 82 in the flushing process.

The system 10 may include one or more controllers, which are capable ofactivating one or more of the pumps 46, 110, 78, and/or one or more ofthe valves 42, 52, 54, 104, 62-70, 72, 74, 76, 80, and/or receivinginput from pressure sensors 112 and/or air sensors 114, 116. For thepurposes of this disclosure, we refer to only one controller, althoughit will be appreciated that multiple controllers may be provided. Thecontroller may be of any appropriate design, such as, for example, aMicrochip PIC18F6410, although an alternate arrangement may be provided.

Returning to FIG. 5, the controller 120 a receives input from thepressure and air sensors 112 a and 114 a, and directs theactuation/operation of the pumps 46 a, 110 a and valves 54 a, 52 a, 104a, 70 a, 72 a, 74 a. In operation, the controller 120 directs theclosure of valves 52 a, 70 a, 72 a, 104 a, the opening of valves 54 a,74 a, and the disengagement of pump 110 a. The controller 120 a thendirects the pump 46 a to pump fluid from the fluid source 22 a to thecontainer 82 a. When the reading received from the pressure sensor 112 areaches a preset first pressure, the controller 120 a directs theopening of the valve 104 a, at which time, fluid and gas from thecontainer 82 a is directed through the valves 104 a, 74 a to the drain34 a. During this time, the controller 120 a directs the continuedoperation of the pump 46 a at a speed sufficient to maintain the presetfirst pressure at pressure sensor 112 a. If the pressure falls below thepreset first pressure, the controller 120 a maintain valve 54 a in theopen position to allow the pump 46 a to continue filling the container82; conversely, if the pressure is above the preset first pressure, thecontroller 120 a directs valve 54 a to remain closed until such time asthe pressure as measured by the pressure sensor 112 a again matches thepreset first pressure.

When the controller 120 a receives a reading of no air from the airsensor 114 a for a set period, the controller 120 a causes the system 10a to operate under regular operation. That is, the controller 120 adirects valves 104 a, 74 a to close and valves 70 a, 72 a to open, anddirects the engagement of pump 110 a to cause the salt solution to flowto the dialyzer 11 a. During regular operation, the controller 120 amaintains a desired second, operating pressure, as measured by thepressure sensor 112 a, the second, operating pressure being lower thanthe preset first pressure. As indicated above, the control of thepressure within the container 82 may be established by the opening andclosing of valve 54 a. In alternate embodiments of the arrangementsshown in both FIGS. 2 and 5, however, control of the pressure within thecontainer 82 may be established by reductions and increases in the speedof the pump 46 a/46, in conjunction with or separate from the openingand closing of valve 54 a/54 and/or valve 52 a/52.

Referring to the embodiment of FIG. 2, a similar arrangement may beprovided for operation of a controller. In various embodiments, thecontroller may receive input from pressure and air sensors 112, 114,116, and may direct the operation of any or all of pumps 46, 110, 78 andany or all of valves 42, 52, 54, 104, 62-70, 72, 74, 76, 80.

By way of example of one such manner of operation of the controller, ina first step, the pump 110 is disabled, valves 104, 52 are closed, andvalve 54 is opened, and the dialyzer 11 is isolated by closing valves70, 72 and opening the bypass valve 74. In the balance chambers, valves62 and 65-69 are opened.

The controller opens valve 54 to allow pump 46 to pump fluid into thecontainer 82. When the pressure sensor 112 indicates that the desired,first pressure has been reached, the controller causes valves 104, 76and 80 to be opened to flush gas and fluid through the container outletthrough the air separation chamber 102, through degassing line 106 andmainline 20 c, and through the balance chamber 26 to mainline 20 d. Thegas and fluid then proceeds through the bypass line 30 b into the airseparation chamber 36. From the air separation chamber 36, the gasesproceed through return line 30 d, through valve 80 to the drain 34.During this flushing step, the controller causes the opening and closingof the valve 54 in conjunction with the continued operation of the pump46 to maintain the desired preset first pressure within the container 82as measured by readings from the pressure sensor 112. After a presetperiod of time, for example, thirty seconds, the pump 78 may beactivated to pump any accumulated fluids from the air separation chamber36 through return line 30 e and balance chamber 28 to the drain 34.

Once no air is detected at the air sensor 114 for a period of time, forexample, two consecutive minutes, the controller causes valve 104 toclose. Once the remainder of the fluid and gas pass through the bypassline 30 b, bypass valve 74 is returned to a closed position, and theremainder of the valves are returned or set to a regular operatingpositions. The pump 110 is then activated, and the controller causes thevalve 54 to open and close, such that the continued operation of thepump 46 provides a second, lower operating pressure at pressure sensor112.

As explained above, the disclosed method may operate to reduce theresidual gases and the gases precipitating from the solution withoutdrawing a vacuum on the container 82. In the initial step, pressure isbuilt in the substantially isolated container 82 until a first presetpressure is obtained. The flushing step is then initiated to flushgases, fluid, and entrained gases from the container to a drain. Eitherafter a preset time or when gas is no longer sensed in the fluid fromthe container 82, the system is returned to a second, lower operatingpressure, and the fluid from the container 82 is directed to thedialyzer 11. In this way, the level of air in the container 82 iseffectively reduced to yield additional space for fluid. Accordingly,this reduction of air allows for effective operation of the container 82in providing a salt solution for dialysis.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. Recitation of ranges of valuesherein are merely intended to serve as a shorthand method of referringindividually to each separate value falling within the range, unlessotherwise indicated herein, and each separate value is incorporated intothe specification as if it were individually recited herein. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended merely to better illuminate the inventionand does not pose a limitation on the scope of the invention unlessotherwise claimed. No language in the specification should be construedas indicating any non-claimed element as essential to the practice ofthe invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

The invention claimed is:
 1. A system for use in a dialysis apparatus,the system comprising: a fluid source; at least one line adapted toallow the passage of fluid, the hydraulic line having a first end influid communication with the fluid source and a second end in fluidcommunication with a drain; an inlet pump disposed along the hydraulicline and in fluid communication with the fluid source; a containercontaining a powdered salt concentrate, the container having an inletand an outlet, the inlet being adapted to receive fluid from the inletpump, and the outlet adapted to pass a solution of the fluid and thesalt concentrate; a valve disposed between the inlet pump and thecontainer and downstream from the inlet pump and in fluid communicationwith the hydraulic line, the valve being disposed to selectively divertfluid flow from the hydraulic line to the inlet of the container; apressure sensor disposed to monitor pressure in the container; theoutlet of the container in fluid communication with the hydraulic linedownstream from the bypass valve; and a controller configured to controloperation of at least one of the inlet pump and the valve in response topressure data provided from the pressure sensor.
 2. The system of claim1 further comprising an air sensor disposed to detect gases in thesolution, the controller being configured to control operation of atleast one of the inlet pump and the valve in response to solution gasdata from the air sensor.
 3. The system of claim 1 further comprising anoutlet pump located downstream from the outlet of the container and influid communication with the hydraulic line.
 4. The system of claim 1further comprising second valve downstream the container.
 5. The systemof claim 1 further comprising an air separation chamber having an inlet,an outlet, wherein the inlet of the air separation chamber is in fluidcommunication with the outlet of the container and the outlet of the airseparation chamber is in fluid communication with the hydraulic linedownstream from the bypass valve.
 6. The system of claim 5 furthercomprising an outlet pump located downstream from the outlet of thecontainer and in fluid communication with the hydraulic line, whereinthe outlet pump is in fluid connection with the outlet of the airseparation chamber.
 7. The system of claim 5 wherein the air separationchamber further comprises a vent, and the system comprises a vent linein fluid connection with the vent and with the hydraulic line.
 8. Thesystem of claim 5 further comprising an air sensor disposed to detectgases in the solution, the air sensor being in communication with theair separation chamber, and the controller being configured to controloperation of at least one of the inlet pump and the valve in response tosolution gas data from the air sensor.
 9. A system for use in a dialysisapparatus, the system comprising: a fluid source; at least one lineadapted to allow the passage of fluid, the hydraulic line having a firstend in fluid communication with the fluid source and a second end influid communication with a drain; an inlet pump disposed along thehydraulic line and in fluid communication with the fluid source; acontainer containing a powdered salt concentrate, the container havingan inlet and an outlet, the inlet being adapted to receive fluid fromthe inlet pump, and the outlet adapted to pass a solution of the fluidand the salt concentrate; a valve disposed downstream from the inletpump and in fluid communication with the hydraulic line, the valve beingdisposed to selectively divert fluid flow from the hydraulic line to theinlet of the container; a pressure sensor disposed to monitor pressurein the container; the outlet of the container in fluid communicationwith the hydraulic line downstream from the bypass valve; an airseparation chamber having an inlet, an outlet, wherein the inlet of theair separation chamber is in fluid communication with the outlet of thecontainer and the outlet of the air separation chamber is in fluidcommunication with the hydraulic line downstream from the bypass valve;and a controller configured to control operation of at least one of theinlet pump and the valve in response to pressure data provided from thepressure sensor.
 10. The system of claim 9 further comprising an outletpump located downstream from the outlet of the container and in fluidcommunication with the hydraulic line, wherein the outlet pump is influid connection with the outlet of the air separation chamber.
 11. Thesystem of claim 9 wherein the air separation chamber further comprises avent, and the system comprises a vent line in fluid connection with thevent and with the hydraulic line.
 12. The system of claim 9 furthercomprising an air sensor disposed to detect gases in the solution, theair sensor being in communication with the air separation chamber, andthe controller being configured to control operation of at least one ofthe inlet pump and the valve in response to solution gas data from theair sensor.